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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PENTA 3MM LEAD, 60 CM; SCS LEAD

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ST. JUDE MEDICAL - NEUROMODULATION PENTA 3MM LEAD, 60 CM; SCS LEAD Back to Search Results
Model Number 3228
Device Problems Disconnection (1171); High impedance (1291)
Patient Problem Device Overstimulation of Tissue (1991)
Event Date 06/27/2018
Event Type  Injury  
Manufacturer Narrative
The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.
 
Event Description
Device 2 of 2.Reference mfr.Report#: 1627487-2018-09041.It was reported the patient was experiencing pocket stimulation.Lead diagnostics showed multiple contacts with high impedances.X-rays confirmed the lead had migrated and the lead had pulled out of the ipg header.The patient also reported not receiving effective therapy (reference mfr.Report#: 1627487-2018-09039 and 1627487-2018-09040 for ineffective stimulation).The patient underwent surgical intervention where the ipg was replaced with a new one.
 
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Brand Name
PENTA 3MM LEAD, 60 CM
Type of Device
SCS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer Contact
kimberly goode
6901 preston road
plano, TX 75024
9723098541
MDR Report Key7891679
MDR Text Key120823368
Report Number1627487-2018-09042
Device Sequence Number1
Product Code GZB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 09/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/28/2016
Device Model Number3228
Device Lot Number4407199
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/07/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age33 YR
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